CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 249 enrolled
Drug / intervention
ADVAIR DISKUS™ 250/50mcg +1 moredrug
Likely dose
Fluticasone Propionate/Salmeterol 250/50 mcg twice dailyAI-extracted
Key inclusion· 4
  • Age ≥50 years
  • Post-albuterol FEV1/FVC ratio ≤0.70 (COPD diagnostic criterion)
  • Post-albuterol FEV1 <80% of predicted normal
  • Smoking history ≥10 pack-years (current or former smoker)
Key exclusion· 3
  • Current diagnosis of asthma
  • BMI ≥35 kg/m²
  • Respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857766
NCT00857766Phase 4Completed

A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·interventional·Posted Mar 9, 2009·Updated Jan 30, 2017

In Brief

A Phase 4 clinical trial evaluating ADVAIR DISKUS™ 250/50mcg and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 249 participants across 24 sites.

Detailed Summary

The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.3 years ago

Interventions

ADVAIR DISKUS™ 250/50mcgdrug

ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Placeboother

COPD subjects-Placebo DISKUS